| 摘要 |
Compositions for the treatment of xerostomia, and methods of making and using thereof are disclosed herein. The compositions are typically in the form of a film or tablet, such as a double layer sticker tablet. The compositions adhere to a buccal surface or mucosal surface in the oral cavity for at least 15 minutes, preferably for at least 30 minutes. The compositions themselves are able to increase the levels of saliva in the mouth without the need for active agents, such sialogogic agents. The compositions optionally contain a non-lipid lubricant, a flavoring agent, and/or a buffering agent. The composition is generally effective at treating or ameliorating the effects of xerostomia for a time period ranging from at least 30 minutes up to eight hours following administration to the buccal or oral mucosa. |
| 主权项 |
1. A double layer bioadhesive sticker tablet for treating or ameliorating the effects of xerostomia in a patient comprising:
a bioadhesive layer comprising
(a) a pharmaceutically acceptable bioadhesive carrier, and(b) a non-lipid lubricant selected from the group consisting of polymers of acrylic acid crosslinked with allyl sucrose or allyl pentaerythritol, copolymers of acrylic acid and C10-C30 alkyl acrylate crosslinked with allyl pentaerythritol, polyethylene glycol having a molecular weight of between about 400 and about 1,000,000 daltons, glycerol, polypropylene glycol, polyvinyl alcohol, polyvinyl pyrrolidone, sodium benzoate, leucine, magnesium stearate, sodium lauryl sulfate, and sodium lauryl sulfoacetate, wherein the non-lipid lubricant is present in an amount from about 10% to about 50% by weight; wherein the tablet, upon application to a mucosal surface, adheres to the mucosal tissue for at least 15 minutes; wherein the tablet does not completely dissolve prior to about 15 minutes following application to a mucosal surface; wherein the tablet does not contain a sialogogic agent, a lipid, or combinations thereof, and wherein salivary flow is increased about 30 minutes following administration. |
